|
Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S027 |
Date Received | 11/16/2007 |
Decision Date | 03/21/2008 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PACKAGE INSERT: 1) INCLUSION OF WARNINGS RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION AND POSSIBLE NERVE COMPRESSION DUE TO ECTOPIC BONE FORMATION PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS; 2) INCLUSION OF CLINICAL AND ADVERSE EVENT DATA RESULTING FROM THE CLINICAL POST APPROVAL STUDY; 3) INCLUSION OF A WARNING RELATED TO ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH OVER STUFFING THE SCAFFOLD COMPONENT INTO A SMALL VOLUME OR HYPERCONCENTRATING THE RECOMBINANT HUMAN PROTEIN COMPONENT; 4) INCLUSION OF REFERENCES TO PREVIOUSLY APPROVED XS AND XXS KITS; AND 5) STRENGTHENING THE LANGUAGE STATING THAT THE COMPONENTS OF THE PRODUCT MAY ONLY BE USED TOGETHER AND NOT WITH OTHER DEVICES OR COMPONENTS, E.G., SCAFFOLDS OTHER THAN THE ACS. |